BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 1213518 · Received October 27, 2008

    Report

    Report Number
    6000034-2008-00600
    Event Type
    Injury
    Date Received
    October 27, 2008
    Report Date
    September 30, 2008
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS, AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT FILED, OCTOBER 27, 2008.

    Description of Event or Problem · 1

    THE PT REPORTED HAVING RECURRING INFECTION AND DRAINING AT THE ABUTMENT SITE. TWO REVISION SURGERIES WERE DONE (DATES NOT REPORTED) BUT DID NOT ALLEVIATE THE PROBLEM. THE PT CURRENTLY IS BEING TREATED WITH ANTIBIOTICS. THE PT IS SCHEDULED FOR A REVISION SURGERY (DATE NOT REPORTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLANGE FIXTURE AND ABUTMENT LXB COCHLEAR BONE ANCHORED SOLUTIONS, AB 90305 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention